[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577180":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":82,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vancomycin","ACTIVE_COMPARATOR","Vancomycin is glycopeptide antibiotic that has broad gram-positive coverage. The current approved dose is 125mg PO every 6 hours for 10 days. Appropriate dosing and tolerance of vancomycin is well defined in both healthy and hospitalized populations, as it is already approved and indicated by the FDA for use in treating C. difficile infection.",[13],"Drug: Vancomycin (POC)",{"label":15,"type":10,"description":16,"interventionNames":17},"Fidaxomicin","Fidaxomicin is a macrolide antibiotic. It is narrow spectrum with potent bactericidal activity specifically against C. difficile. The approved dose is 200mg PO twice daily for 10 days. Appropriate dosing and tolerance of fidaxomicin is well defined in both healthy and hospitalized populations, as it is already approved and indicated by the FDA for use in treating C. difficile infection.",[18],"Drug: Fidaxomicin",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Vancomycin (POC)","Vancomycin is glycopeptide antibiotic that has broad gram-positive coverage. Patients will receive 125mg PO every 6 hours for 10 days.",[9],null,{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Fidaxomicin is a macrolide antibiotic. It is narrow spectrum with potent bactericidal activity specifically against C. difficile. Patients will receive 200mg PO twice daily for 10 days.",[15],[30],{"name":31,"affiliation":5,"role":32},"Jessica Allegretti, MD, MPH","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Alexander Carlin","CONTACT","6175257322","acarlin@bwh.harvard.edu",{"name":31,"role":36,"phone":40,"phoneExt":25,"email":41},"6177326389","jallegretti@bwh.harvard.edu",[43],{"facility":5,"status":25,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Boston","Massachusetts","02115","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-71.05977,42.35843,{"lat":53,"lon":52},[56],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},{"type":32,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Jessica Ravikoff Allegretti","Jessica Ravikoff Allegretti, MD, MPH, FACG, AGAF, Principal Investigator","100577180","phase-4-use-of-fidaxomicin-compared-to-vancomycin-for-decolonization-of-c-difficile-in-patients-with-inflammatory-bowel-disease-100577180",false,"NCT06794944","Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Male or female \\> 18 years of age.\n3. IBD diagnosis (CD, UC or indeterminant Colitis will be permitted.)\n4. Presenting for outpatient colonoscopy for any indication.\n\nExclusion Criteria:\n\n1. Unable to provide consent.\n2. Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy.)\n3. Unable to complete study procedures.\n4. Chronic use of antibiotics.\n5. Inability or unwillingness to swallow capsules.\n6. Allergy or sensitivity to vancomycin, fidaxomicin, or microcrystalline cellulose.","ALL","18 Years",{"count":69,"type":70},60,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","This is a randomized, double-blind study to assess the safety and efficacy of fidaxomicin compared to vancomycin for decolonization of C. difficile in IBD patients. A total of 60 patients who meet eligibility criteria will be randomized 1:1 to either the fidaxomicin or vancomycin arm. The vancomycin arm will receive a dose of 125 mg PO q 6 hours for 10 days. The fidaxomicin arm will receive 200 mg PO BID for 10 days. In order to ensure blinding, both antibiotics will be concealed in opaque 00 capsule shells. In addition, those in the fidaxomicin arm will receive 2 placebo capsules so that all participants will receive 4 capsules daily for 10 days. Microbiome assessment and C. difficile testing will be performed at baseline, day 5, day 10, and weeks 4, 8, and 26.",[76,77],"Inflammatory Bowel Disease (IBD)","Clostridioides Difficile Infection",[79,80,81],"C. difficile","Crohn's Disease","Ulcerative Colitis","NOT_YET_RECRUITING","2025-10-31",{"date":85,"type":86},"2025-11-03","ACTUAL",{"date":88,"type":70},"2026-09",{"date":90,"type":70},"2031-09",{"name":5,"class":6},1]